Electrosurgical wand and related method and system

ABSTRACT

An electrosurgical wand. At least some of the illustrative embodiments are electrosurgical wands including an elongate housing that defines a handle end and a distal end, a first discharge aperture on the distal end of the elongate housing, a first active electrode of conductive material disposed on the distal end of the elongate housing, a first return electrode of conductive material disposed within the first fluid conduit, and an aspiration aperture on the distal end of the elongate housing fluidly coupled to a second fluid conduit.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.12/905,386 filed Oct. 15, 2010, the complete disclosure of which isincorporated herein by reference for all purposes.

BACKGROUND

In the treatment of chronic wounds (e.g., diabetic foot ulcers)electrosurgical procedures may be used to promote healing. Inparticular, electrosurgical procedures may be used for debriding thewound, inducing blood flow to the wound, coagulating blood flow from thewound, removing necrotic tissue, and/or removing bacterial films whichmay form (the bacterial films sometimes referred to as “biofilm”). Inmany cases wounds are considered “dry” in the sense that there isinsufficient conductive fluid present to support plasma creation forelectrosurgical procedures. In such cases a conductive fluid (e.g.,saline) is provided to help support plasma creation.

However, in providing a conductive fluid to a wound to help supportplasma creation, the location of the wound and/or the orientation of thepatient may adversely impact how the conductive fluid is distributed.For example, gravity may cause the conductive fluid to flow in such away as to not fully “wet” one or more of the electrodes involved in theplasma creation, thus limiting or preventing plasma creation.

Any advance that better controls distribution of conductive fluid in andaround the electrodes of an electrosurgical system would provide acompetitive advantage.

BRIEF DESCRIPTION OF THE DRAWINGS

For a detailed description of exemplary embodiments, reference will nowbe made to the accompanying drawings in which:

FIG. 1 shows an electrosurgical system in accordance with at least someembodiments;

FIG. 2A shows a perspective view a portion of a wand in accordance withat least some embodiments;

FIG. 2B shows a partial cross-sectional view taken substantially alongline 2B-2B of FIG. 2A;

FIG. 3 shows a front elevation view of a wand in accordance with atleast some embodiments;

FIG. 4 shows a side elevation, with partial cut-away, view of a wand inaccordance with at least some embodiments;

FIG. 5 a side elevation view of a wand in operational relationship to awound in accordance with at least some embodiments;

FIG. 6 shows a front elevation view of a wand in accordance with atleast some embodiments;

FIG. 7 shows a front elevation view of a wand in accordance with atleast some embodiments;

FIG. 8 shows a front elevation view of a wand in accordance with atleast some embodiments;

FIG. 9 shows both an elevation end-view (left) and a cross-sectionalview (right) of a wand connector in accordance with at least someembodiments;

FIG. 10 shows both an elevation end-view (left) and a cross-sectionalview (right) of a controller connector in accordance with at least someembodiments;

FIG. 11 shows an electrical block diagram of an electrosurgicalcontroller in accordance with at least some embodiments; and

FIG. 12 shows a method in accordance with at least some embodiments.

NOTATION AND NOMENCLATURE

Certain terms are used throughout the following description and claimsto refer to particular system components. As one skilled in the art willappreciate, companies that design and manufacture electrosurgicalsystems may refer to a component by different names. This document doesnot intend to distinguish between components that differ in name but notfunction.

In the following discussion and in the claims, the terms “including” and“comprising” are used in an open-ended fashion, and thus should beinterpreted to mean “including, but not limited to . . . .” Also, theterm “couple” or “couples” is intended to mean either an indirect ordirect connection. Thus, if a first device couples to a second device,that connection may be through a direct connection or through anindirect electrical connection via other devices and connections.

Reference to a singular item includes the possibility that there areplural of the same items present. More specifically, as used herein andin the appended claims, the singular forms “a,” “an,” “said” and “the”include plural references unless the context clearly dictates otherwise.It is further noted that the claims may be drafted to exclude anyoptional element. As such, this statement serves as antecedent basis foruse of such exclusive terminology as “solely,” “only” and the like inconnection with the recitation of claim elements, or use of a “negative”limitation. Lastly, it is to be appreciated that unless definedotherwise, all technical and scientific terms used herein have the samemeaning as commonly understood by one of ordinary skill in the art towhich this invention belongs.

“Active electrode” shall mean an electrode of an electrosurgical wandwhich produces an electrically-induced tissue-altering effect whenbrought into contact with, or close proximity to, a tissue targeted fortreatment.

“Return electrode” shall mean an electrode of an electrosurgical wandwhich serves to provide a current flow return path with respect to anactive electrode, and/or an electrode of an electrical surgical wandwhich does not itself produce an electrically-induced tissue-alteringeffect on tissue targeted for treatment.

A fluid conduit said to be “within” an elongate housing shall includenot only a separate fluid conduit that physically resides within aninternal volume of the elongate housing, but also situations where theinternal volume of the elongate housing is itself the fluid conduit.

Where a range of values is provided, it is understood that everyintervening value, between the upper and lower limit of that range andany other stated or intervening value in that stated range isencompassed within the invention. Also, it is contemplated that anyoptional feature of the inventive variations described may be set forthand claimed independently, or in combination with any one or more of thefeatures described herein.

All existing subject matter mentioned herein (e.g., publications,patents, patent applications and hardware) is incorporated by referenceherein in its entirety except insofar as the subject matter may conflictwith that of the present invention (in which case what is present hereinshall prevail). The referenced items are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present invention isnot entitled to antedate such material by virtue of prior invention.

DETAILED DESCRIPTION

Before the various embodiments are described in detail, it is to beunderstood that this invention is not limited to particular variationsset forth herein as various changes or modifications may be made, andequivalents may be substituted, without departing from the spirit andscope of the invention. As will be apparent to those of skill in the artupon reading this disclosure, each of the individual embodimentsdescribed and illustrated herein has discrete components and featureswhich may be readily separated from or combined with the features of anyof the other several embodiments without departing from the scope orspirit of the present invention. In addition, many modifications may bemade to adapt a particular situation, material, composition of matter,process, process act(s) or step(s) to the objective(s), spirit or scopeof the present invention. All such modifications are intended to bewithin the scope of the claims made herein.

FIG. 1 illustrates an electrosurgical system 100 in accordance with atleast some embodiments. In particular, the electrosurgical systemcomprises an electrosurgical wand 102 (hereinafter “wand”) coupled to anelectrosurgical controller 104 (hereinafter “controller”). The wand 102comprises an elongate housing 106 that defines distal end 108 where atleast some electrodes are disposed. The elongate housing 106 furtherdefines a handle or proximal end 110. The wand 102 further comprises aflexible multi-conductor cable 112 housing a plurality of electricalleads (not specifically shown in FIG. 1), and the flexiblemulti-conductor cable 112 terminates in a wand connector 114. As shownin FIG. 1, the wand 102 couples to the controller 104, such as by acontroller connector 120 on an outer surface 122 (in the illustrativecase of FIG. 1, the front surface).

Though not visible in the view of FIG. 1, in some embodiments the wand102 has one or more internal lumens or fluid conduits coupled toexternally accessible tubular members. As illustrated, the wand 102 hasa first flexible tubular member 116 and a second flexible tubular member118. In some embodiments, the flexible tubular member 116 is used toprovide saline to the distal end 108 of the wand. Likewise in someembodiments, flexible tubular member 118 is used to provide suction foraspiration at the distal end 108 of the wand. In some embodiments, theflexible tubular member 116 is a hose having a 0.152 inch outsidediameter, and a 0.108 inch inside diameter, but other sizes may beequivalently used. Further, in some embodiments the flexible tubularmember 118 is a hose having a 0.25 inch outside diameter, and a 0.17inch internal diameter, but other sizes may be equivalently used.

Still referring to FIG. 1, the controller 104 controllably providesenergy to the wand 102 for the electrosurgical procedures (discussedmore below). A display device or interface panel 124 is visible throughthe outer surface 122 of the controller 104, and in some embodiments auser may select operational modes of the controller 104 by way of theinterface device 124 and related buttons 126.

In some embodiments the electrosurgical system 100 also comprises a footpedal assembly 130. The foot pedal assembly 130 may comprise one or morepedal devices 132 and 134, a flexible multi-conductor cable 136 and apedal connector 138. While only two pedal devices 132, 134 are shown,one or more pedal devices may be implemented. The outer surface 122 ofthe controller 104 may comprise a corresponding connector 140 thatcouples to the pedal connector 138. The foot pedal assembly 130 may beused to control various aspects of the controller 104, such as theoperational mode. For example, a pedal device, such as pedal device 132,may be used for on-off control of the application of radio frequency(RF) energy to the wand 102. A second pedal device, such as pedal device134, may be used to control and/or set the operational mode of theelectrosurgical system. For example, actuation of pedal device 134 mayswitch between energy levels. In yet still further embodiments, the wand102 may further comprises switches accessible on an outside portion,where the switches may control the operational modes of the controller104.

The electrosurgical system 100 of the various embodiments may have avariety of operational modes. One such mode employs Coblation®technology. In particular, the assignee of the present disclosure is theowner of Coblation® technology. Coblation® technology involves theapplication of an RF energy between one or more active electrodes andone or more return electrodes of the wand 102 to develop high electricfield intensities in the vicinity of the target tissue. The electricfield intensities may be sufficient to vaporize an electricallyconductive fluid over at least a portion of the one or more activeelectrodes in the region near the one or more active electrodes and thetarget tissue. Electrically conductive fluid may be inherently presentin the body, such as blood, puss, or in some cases extracellular orintracellular fluid. In other embodiments, the electrically conductivefluid may be a liquid or gas, such as isotonic saline. In a particularembodiment of wound treatment, the electrically conductive fluid isdelivered in the vicinity of the active electrode and/or to the targetsite by the wand 102, such as by way of the internal fluid conduit andflexible tubular member 116.

When the electrically conductive fluid is heated to the point that theatoms of the fluid vaporize faster than the atoms recondense, a gas isformed. When sufficient energy is applied to the gas, the atoms collidewith each other causing a release of electrons in the process, and anionized gas or plasma is formed (the so-called “fourth state ofmatter”). Stated otherwise, plasmas may be formed by heating a gas andionizing the gas by driving an electric current through the gas, or bydirecting electromagnetic waves into the gas. The methods of plasmaformation give energy to free electrons in the plasma directly,electron-atom collisions liberate more electrons, and the processcascades until the desired degree of ionization is achieved. A morecomplete description of plasma can be found in Plasma Physics, by R. J.Goldston and P. H. Rutherford of the Plasma Physics Laboratory ofPrinceton University (1995), the complete disclosure of which isincorporated herein by reference.

As the density of the plasma becomes sufficiently low (i.e., less thanapproximately 1020 atoms/cm³ for aqueous solutions), the electron meanfree path increases such that subsequently injected electrons causeimpact ionization within the plasma. When the ionic particles in theplasma layer have sufficient energy (e.g., 3.5 electron-Volt (eV) to 5eV), collisions of the ionic particles with molecules that make up thetarget tissue break molecular bonds of the target tissue, dissociatingmolecules into free radicals which then combine into gaseous or liquidspecies. Often, the electrons in the plasma carry the electrical currentor absorb the electromagnetic waves and, therefore, are hotter than theionic particles. Thus, the electrons, which are carried away from thetarget tissue toward the active or return electrodes, carry most of theplasma's heat, enabling the ionic particles to break apart the targettissue molecules in a substantially non-thermal manner.

By means of the molecular dissociation (as opposed to thermalevaporation or carbonization), the target tissue is volumetricallyremoved through molecular dissociation of larger organic molecules intosmaller molecules and/or atoms, such as hydrogen, oxygen, oxides ofcarbon, hydrocarbons and nitrogen compounds. The molecular dissociationcompletely removes the tissue structure, as opposed to dehydrating thetissue material by the removal of liquid within the cells of the tissueand extracellular fluids, as occurs in related art electrosurgicaldesiccation and vaporization. A more detailed description of themolecular dissociation can be found in commonly assigned U.S. Pat. No.5,697,882, the complete disclosure of which is incorporated herein byreference.

In addition to the Coblation® mode, the electrosurgical system 100 ofFIG. 1 may also in particular situations be useful for sealing bloodvessels, when used in what is known as a coagulation mode. Thus, thesystem of FIG. 1 may have an ablation mode where RF energy at a firstvoltage is applied to one or more active electrodes sufficient to effectmolecular dissociation or disintegration of the tissue, and the systemof FIG. 1 may have a coagulation mode where RF energy at a second, lowervoltage is applied to one or more active electrodes sufficient to heat,shrink, seal, fuse, and/or achieve homeostasis of severed vessels withinthe tissue.

The energy density produced by electrosurgical system 100 at the distalend 108 of the wand 102 may be varied by adjusting a variety of factors,such as: the number of active electrodes; electrode size and spacing;electrode surface area; asperities and/or sharp edges on the electrodesurfaces; electrode materials; applied voltage; current limiting of oneor more electrodes (e.g., by placing an inductor in series with anelectrode); electrical conductivity of the fluid in contact with theelectrodes; density of the conductive fluid; and other factors.Accordingly, these factors can be manipulated to control the energylevel of the excited electrons. Since different tissue structures havedifferent molecular bonds, the electrosurgical system 100 may beconfigured to produce energy sufficient to break the molecular bonds ofcertain tissue but insufficient to break the molecular bonds of othertissue.

A more complete description of the various phenomena can be found incommonly assigned U.S. Pat. Nos. 6,355,032; 6,149,120 and 6,296,136, thecomplete disclosures of which are incorporated herein by reference.

FIG. 2A illustrates a perspective view of the distal end 108 of wand 102in accordance with at least some embodiments. In particular, theillustrative system of FIG. 2A has two discharge apertures 200 and 202,an aspiration aperture 204, two active electrodes 206 and 208, tworeturn electrodes 210 and 212, along with a support member 214.Moreover, the illustrative distal end 108 defines a width (labeled W inthe figure) and a thickness (labeled T in the figure). Each of thecomponents will be discussed in turn.

The support member 214 is coupled to the elongate housing 106. In aparticular embodiment, the elongate housing 106 and handle 110 (FIG. 1)are made of a non-conductive plastic material, such as polycarbonate. Inyet other embodiments, the handle 110 and/or elongate housing 106 may beconstructed in whole or in part of metallic material, but for reasonsdiscussed more below the metallic material is non-grounded and/or doesnot provide a return path for electrons to the controller 104. Further,support member 214 is a non-conductive material resistant to degradationwhen exposed to plasma. In some cases support member 214 is made of aceramic material (e.g., alumina ceramic), but other non-conductivematerials may be equivalently used (e.g., glass). An illustrative twodischarge apertures 200 and 202 are defined within the support member214. The discharge apertures are rectangular with rounded corners, andwhere the long dimensions of the apertures 200 and 202 are aligned withthe width W. Rectangular shaped discharged apertures are merelyillustrative, and any suitable shape may be equivalently used (e.g.,circular, oval, square). Within the support member 214 each aperture 200and 202 defines a fluid conduit 216 and 218, respectively. Each fluidconduit is fluidly coupled within the elongate housing 106 to flexibletubular member 116 (FIG. 1), through which conductive fluid is pumped orgravity fed during use. Thus, during use, conductive fluid flows intothe flexible tubular member 116 (FIG. 1), through one or more fluidconduits (not specifically shown) within the elongate housing 106,through the fluid conduits 216 and 218 defined through thenon-conductive support member 214, and out of the discharge apertures200 and 202.

In the various embodiments, the conductive fluid has conductivity abovea minimum threshold. More particularly, the conductive fluid will haveconductivity greater than 0.2 milli-Siemens per centimeter (mS/cm), insome cases greater than about 2 mS/cm, and in other cases greater thanabout 10 mS/cm. An example of the conductive fluid that may be used isisotonic saline, having conductivity of about 17 mS/cm. During wounddebridement, saline may flow at the rate of between and including 30 and70 milli-Liters per min (mL/min), but may vary depending on factors suchas: the pressure at the aspiration aperture 204; the geometry, materialproperty and configuration of the return electrodes 210 and 212; thegeometry, material properties and configuration of the active electrodes206 and 208; and the geometry, material properties and configuration ofthe support member 214.

Still referring to FIG. 2A, the illustrative the distal end 108 furthercomprises two active electrodes 206 and 208. Each active electrode is ametallic structure, around which plasma is created during use in someoperational modes. In some case, the wire is stainless steel, but othertypes of metallic wire (e.g., tungsten, molybdenum) may be equivalentlyused. As illustrated, each active electrode 206 and 208 is a loop ofwire having a particular diameter. Smaller diameter wire for the activeelectrodes advantageously results in less thermal heating of the tissue,but there is a tradeoff with wire strength, as smaller wire diameterstend to break and/or bend more easily. In some embodiments, the wirediameter for each active electrode is between and including 0.008 and0.015 inches, and in a particular case 0.010 inches. Using activeelectrode 206 as exemplary of both active electrodes, the illustrativeactive electrode 206 comprises a straight portion 220, as well as twostandoff portions 222 (labeled 222A and 222B). In a particularembodiment (and as illustrated) the straight portion 220 resides overthe respective discharge aperture 200. “Over” in this instance does notimply an orientation of the distal end 108 of the wand 102; rather,“over” is only meant to imply that if the fluid conduit 216 wasprojected outward past the discharge aperture 200, at least a portion ofthe straight portion 220 would reside within the projected area. Inother cases the active electrodes need not be over the dischargeapertures, so long as the active electrodes reside in the conductivefluid path between the discharge apertures 200 and 202 and theaspiration aperture 204.

In accordance with at least some embodiments, the length of the straightportion 220 is between and including 0.16 and 0.18 inches. Moreover,standoff portions 222 define an exposed length of about between andincluding 0.010 and 0.050 inches, and in some cases between andincluding 0.015 and 0.025 inches. In these embodiments the lengthdefined by the standoff portions 222 is measured from the surface 250defined by the support member 214 to the central axis of the straightportion 220. It will be understood, however, that the standoff portions222 may extend into the support member 214, and thus will be longer thanthe exposed length. However, other straight portion 220 and standoffportion 222 lengths may be equivalently used. For the example wirediameters and lengths of this paragraph, the exposed surface area ofeach active electrode (i.e., that portion residing outside thenon-conductive support member 214) may be between and including 0.00447and 0.04141 square inches.

Still referring to active electrode 206 as illustrative of both activeelectrodes, the active electrode 206 is electrically coupled to thecontroller 104 (FIG. 1). In some cases, the active electrode 206 iscoupled to the controller by way of one of the standoff portions 222 andan insulated conductor (not specifically shown) that runs through theelongate housing 106. Thus, by way of the cable 112 (FIG. 1) andelectrical pins (shown in FIG. 9 below) in the connector 114 (FIG. 1),the active electrode 206 couples to the controller 104 (FIG. 1). In somecases the active electrodes all couple to the controller 104 by way ofthe same electrical pin, and in other cases each active electrode maycouple to the controller by way of its own electrical pin.

The straight portions of the active electrodes in FIG. 2A are parallel.However, the arrangement of FIG. 2A is merely illustrative. The activeelectrodes may take any suitable shape, and any suitable orientationbetween them. For example, the straight portions of the activeelectrodes may be coaxial. Further still, straight portions of theactive electrodes may form an obtuse angle. Yet further still, theactive electrodes may take any suitable form, such as a sinusoid betweenthe standoffs 222, or saw tooth pattern between the standoffs 222. Inmany cases, regardless of the form of the active electrodes, each activeelectrode 206 and 208 has approximately the same standoff distance fromthe plane defined by the outer surface 250 of the support member 214.

Still referring to FIG. 2A, the distal end 108 further comprises returnelectrodes 210 and 212 associated with each active electrode 206 and208, respectively. Each return electrode is made of conductive material,which conductive material forms a return path for electrical currentassociated with energy applied to the active electrodes. In theillustrative embodiments of FIG. 2A, each return electrode 210 and 212comprises metallic wire. In some case, the wire is stainless steel, butother types of metallic wire (e.g., titanium, molybdenum) may beequivalently used. Further, each illustrative return electrode 210 and212 is associated with a discharge aperture 200 and 202, respectively.Using return electrode 212 as exemplary of both return electrodes, theillustrative return electrode 212 comprises the conductive materialdisposed within the fluid conduit 218 such that at least some of theconductive fluid flowing through the fluid conduit 218 contacts thereturn electrode 212 before discharging through the discharge aperture202. In a particular embodiment, and as illustrated, the returnelectrode 212 resides at a sufficient distance within the fluid conduit(i.e., a recess distance) that no portion of the return electrode 212extends through the plane defined by the discharge aperture 212. Havingthe return electrodes disposed within the fluid conduit 202 reduces thechances that the return electrode contacts the tissue of the treatmentarea, and thus reduces the chance of thermal heating. In accordance withat least some embodiments, the return electrode 212 is recessed withinthe fluid conduit between and including 0.020 and 0.030 inches measuredfrom the aperture 202; however, the recess distance and the exposedlength of the standoff portions 222 are related in that the distancebetween an active electrode and a corresponding return electrode shouldbe 0.030 inches or greater (measured from the active to the closestexposed portion of the return electrode). Shorter distances may beoperational, but there is an increased tendency for arcing directlybetween the active and return electrodes to occur. Thus, in embodimentswhere a portion of the active electrode is disposed over a dischargeaperture, as the exposed length of the standoff portions is shorter, therecess distance may be increased.

As illustrated, the return electrode 212 comprises a coil of wire havingan uncoiled length of between and including 0.5 to 3.0 inches. The wirediameter in these embodiments may be between and including 0.010 and0.020 inches. For the particular case of each return electrode being acoil of wire having an uncoiled length of 1.08 inches and a diameter of0.012 inches, the exposed surface area of each return electrode will beapproximately 0.0404 square inches. In accordance with at least someembodiments, the wire diameter and length of the return electrodes areselected such that the exposed surface of the return electrodes isgreater than the exposed surface area of the active electrodes. Returnelectrode 212 in the form of a coil of wire defines a central axis, andin the illustrative embodiments of FIG. 2 the central axis of the coilof wire is parallel to the straight portion of the loop of wire 208;however, other arrangements may be equivalently used.

Still referring to return electrode 212 as illustrative of both returnelectrodes, the return electrode 212 is electrically coupled to thecontroller 104 (FIG. 1). In some cases, the return electrode 212 iscoupled to the controller by way of an insulated conductor (notspecifically shown) that runs through the elongate housing 106. Thus, byway of the cable 112 (FIG. 1) and electrical pins (shown in FIG. 9below) in the connector 114 (FIG. 1), the return electrode couples tothe controller 104 (FIG. 1). In some cases the return electrodes allcouple to the controller 104 by way of the same electrical pin, and inother cases each return electrode may couple to the controller by way ofits own electrical pin.

Having the return electrodes 210 and 212 within the fluid conduits 216and 218, respectively, aids in operation of the wand 102 for wound carein several ways. First, having the return electrodes 210 and 212 withinthe fluid conduits 216 and 218, respectively, increases the likelihoodthat the conductive fluid used to wet the electrodes makes good contactwith both the active and return electrodes in spite of the orientationof the wand 102. Stated otherwise, regardless of the orientation of thewand 102 with respect to gravity, the conductive fluid provided to thewound treatment site has a better chance of contacting both returnelectrodes. By comparison, wands that implement the return electrode byway of conductive material on a shaft may have difficulty ensuring goodwetting of both the active and return electrodes by way of theconductive fluid in some physical orientations. Second, placement of thereturn electrodes 210 and 212 in the fluid conduits 216 and 218,respectively, helps diffuse the conductive fluid proximate the distalend 108 of the wand 102, which further aids in ensuring good wetting,particularly wetting of the associated active electrodes.

FIG. 2A also illustrates that a wand 102 in accordance with at leastsome embodiments further comprises an aspiration aperture 204. Theaspiration aperture 204 is fluidly coupled to the flexible tubularmember 118 (FIG. 1) by way of fluid conduit (not specifically shown)within the wand 102. Thus, and as the name implies, the aspirationaperture 204 is used to remove byproducts of wound treatment using thewand 102, such as removal of excess conductive fluid, molecularlydisassociated tissue, and tissue separated from the wound but otherwisestill intact. As illustrated, the aspiration aperture 204 has a width“W_(a)” approximately the same as the support member 214, and thusslightly wider than the active electrodes. Moreover, in some embodimentsthe height “H” of the aspiration aperture is a function of the standoffdistance of the active electrodes. In some cases the height H may begreater than or equal to three times (i.e., 3 to 1) the exposed lengthof the standoff portions, in other cases greater than or equal to sixtimes (i.e., 6 to 1) the exposed length of the standoff portions, and inyet further cases greater than or equal to ten times (i.e., 10 to 1) theexposed length of the standoff portions. For example, with an exposedlength of the standoff portions being in the range 0.015 to 0.025inches, and a 6-to-1 relationship, the aspiration aperture height may beon the order 0.09 to 0.155 inches, respectively.

In operation of the various embodiments, aggressive aspiration iscontemplated to help remove larger pieces of tissue not molecularlydisassociated (discussed more below). In some cases, the aspiration maybe created by an applied pressure between and including 100 millimetersof mercury (mmHg) and 400 mmHg below atmospheric. However, in some casesaggravation of an existing wound may occur if the aspiration aperture204 is allowed to seal against the wound. In order to reduce thepossibility of the aspiration aperture 204 sealing against the woundand/or patient, and as illustrated, in some embodiments at least aportion of the aspiration aperture is closer to the handle 110 (FIG. 1)than any portion of the discharge apertures. In particular, portion 230is closer to the handle than portions 232A and 232B. Thus, when thedistal end 108 is held in an orientation where the active electrodes 206and 208 can interact with the wound, the likelihood of the aspirationaperture 204 sealing against the wound and/or patient are drasticallyreduced. In yet still further embodiments, optional apertures 250 (threeillustrative apertures labeled 250A through 250C) may be implemented toensure that if, by chance, the aperture 204 seals against the wound, thewound will not be subjected to the full force of the aspiration suctionas air may flow into the apertures 250. Other mechanisms to reduce thelikelihood of sealing of the aperture as discussed below.

FIG. 2B shows an overhead cross-sectional view taken substantially alonglines 2B-2B of FIG. 2A. In particular, FIG. 2B shows the aspirationaperture 204 as well as a fluid conduit 270 defined by walls 272. Inoperation, suction is provided to the flexible tubular member 116 (FIG.1), and flexible tubular member 118 either extends into the internalvolume of the wand 102 to become, or fluidly couples to, internal lumen274. Thus, conductive fluid, molecularly disassociated tissue, as wellas tissue pieces (discussed more below), are drawn through theaspiration aperture 204, into the fluid conduit 270, and eventually intothe lumen 274. The inventors of the present specification have foundthat particular length of the fluid conduit 270 between aspirationaperture 204 and the entrance to the internal lumen 274 work better thanothers. For example, if the length is too short, the fluid conduit 270is subject to clogging. Likewise, if the length is too long, zones oflittle or no airflow develop, again leading to clogging. In accordancewith at least some embodiments the length of the fluid conduit 270between the aperture 204 and the entrance to the internal lumen 274 is afunction of the width W_(a) of the aspiration aperture at the widestpoint. More particularly, in accordance with at least some embodimentsthe internal walls 276 that define the fluid conduit 270 should besmoothly varying, and the length “L” over which the width changes shouldbe at least two times the change in width, and in most cases not longerthan eight times the change in width. Consider, as an example, a wandwhere the W_(a) is 0.39 inches (about 10 millimeters (mm)), and theinternal diameter of the lumen 274 is 0.118 inches (3 mm). In such asituation the change in internal width of the fluid conduit 270 betweenthe aspiration aperture 204 and the entrance to the lumen 274 will beabout 0.272 inches (about 7 mm), and in at least some embodiments thelength L over which the change in width is implemented should be atleast 0.544 inches (at least 14 mm). In a particular embodiment thechange in internal width to the length L is related as:L=(W _(a)−ID)*2.3   (1)where ID is the internal diameter of the lumen 274. Thus, for example, afluid conduit 270 associated with an aspiration aperture in operationalrelationship to a wand 102 with a single active electrode will have ashorter length than in the transition to the internal lumen than a fluidconduit 270 associated with an aspiration aperture in operationalrelationship to a wand 102 with three or more active electrodes.

The inventors present the characteristic of the length L of FIG. 2B interms of the width W_(a) of the aspiration aperture for sake ofsimplicity. Further, equivalent, relationships may be determined, forexample, based on changes in cross-sectional area of the fluid conduit270 taking into account the height H (FIG. 2A) in relation to thestandoff distances implemented by the standoff portions 222. Moreover,while FIG. 2B shows each wall 276 of the fluid conduit 270 to besmoothly varying similar to a tangent function (i.e., asymptoticallyapproaching the W_(a) on one end, and asymptotically approaching theinternal diameter of the lumen 252 on the other), other smoothly varyinginternal surfaces may be equivalently used (e.g., straight line changein W_(a) from the aperture 204 to the internal diameter of the lumen252, asymptotically approaching the internal diameter of the lumen 252).

FIG. 3 shows a front elevation view of the distal end 108 of the wand102 in accordance with at least some embodiments. In particular, theview of FIG. 3 better shows the relationship of the active electrodes206 and 208 to the discharge apertures 200 and 202, respectively. Activeelectrode 206 is shown over the discharge aperture 200. Likewise, activeelectrode 208 is over the discharge aperture 202. Thus, as conductivefluid is discharged through the discharge apertures 200 and 202, thechance the conductive fluid will contact the active electrodes is high,regardless of the orientation of the wand 102 in relation to gravity.Again, however, in other embodiments the active electrodes need not bedisposed over the discharge apertures.

In FIG. 3, the active electrodes are offset along the thickness T. Inparticular, active electrode 206 is closer to the aspiration aperture204 than active electrode 208. While in some embodiments the activeelectrodes have the same elevation with respect to the thickness T, inthe illustrative embodiments there is an overlap 300. The overlap 300 ofthe active electrodes ensures that, in operation, the surface leftwithin the wound is less likely to have any ridges or elevation changescaused by non-uniformity of the active electrodes.

FIG. 3 also illustrates alternative return electrodes. In particular,FIG. 3 illustrates return electrodes in form of a metallic wire mesh.Wire mesh 302 resides within the fluid conduit defined by dischargeaperture 200, and wire mesh 304 resides within the fluid conduit definedby discharge aperture 202. In some cases, the wire mesh is placed suchthat no portion of the wire mesh extends beyond a plane defined by theaspiration apertures 200 and 202, to reduce the chances of the returnelectrodes contacting tissue of the wound. As with the return electrodesin the form of a coil of wire, the wire mesh return electrodes 302 and304 residing within the fluid conduits ensure good wetting of the returnelectrodes during use regardless of the orientation of the wand 102during use. Moreover, the wire mesh return electrodes 302 and 304diffuse the conductive fluid flow, which again increases the likelihoodof good wetting of the respective active electrodes. The wire meshreturn electrodes 302 and 304 define an exposed surface area, and in atleast some embodiments the surface area of the wire mesh returnelectrodes is greater than the exposed surface area of the activeelectrodes 206 and 208.

FIG. 4 shows a side elevation view of the distal end 108 of a wand 102,and including a partial cut-away in the area of the return electrode212, in accordance with various embodiments. In the view of FIG. 4, theoffset of the active electrodes 206 and 208 to enable the overlap 300(not shown in FIG. 4) is visible. Here again, while FIG. 4 shows theactive electrodes 206 and 208 to be parallel, other embodiments,including embodiments with overlap, may be fashioned where the outerportions of the active electrodes form an angle of greater or lesserthan 180 degrees. FIG. 4 also shows the exposed length of the standoffportions 222 (labeled “S” in the figure), as well as the recess of theillustrative return electrode 212 within the fluid conduit 218 (labeled“R” in the figure).

FIG. 4 further illustrates a relationship between the face of thesupport member 214 and the aspiration aperture 204 in accordance with atleast some embodiments. In particular, in order to reduce the likelihoodof the aspiration aperture 204 sealing against the wound, in theembodiments illustrated by FIG. 4 the aspiration aperture 204 is offsettoward the handle end of the wand 102. More particularly, the front faceof the support member 214 defines a plane 400, and the aspirationaperture defines a plane 402. The planes 400 and 402 are parallel in theembodiments of FIG. 4, and the plane 402 associated with the aspirationaperture 214 is closer to the handle 110 (FIG. 1) than the plane 400. Insome embodiments, the offset between the two illustrative planes may bebetween and including 0.030 and 0.060 inches.

FIG. 5 shows a side elevation view of the distal end 108 of wand 102 inuse for wound care. In particular, the wand 102 is shown physicallyabutting wound 500, such as diabetic foot ulcer, and FIG. 5 alsoillustrates the wand 102 ablating portions of the wound 500. Inoperation, electrical energy is applied to the active electrodes, buthere only active electrode 208 is visible. The energy in the example ofFIG. 5 is sufficient to create plasma near the active electrodes, whichthus molecularly disassociates tissue that comes in relatively closecontact with the active electrodes. However, the arrangement of theactive electrodes is such that the reach of the plasma is less than theexposed standoff distance of each active electrode from the planedefined by the front face of the support member 214. Thus, when operatedwith sufficient energy to create plasma, as the wand is translated alongthe wound (as illustrated by arrow 510) the active electrodes act toslice portions of the tissue, rather than attempting to completelymolecularly disassociate the tissue. The result is strips of tissue 502(multiple strips labeled 502A through 502C) are created, and whichstrips of tissue 502 (as well as conductive fluid and remnants of tissuemolecularly disassociated) are drawn into the aspiration aperture 204 bythe aspiration action. The inventors of the present specification havefound that the situation illustrated by FIG. 5 is particularly efficientat debridement of wounds (e.g., removing biofilm). While not wanting tobe tied to any particular theory of why the treatment works well, it isbelieved that the plasma created by the wand 102 is particularlyefficient at destroying bacteria. Moreover, it is believed that the“slicing” action in combination with the aggressive aspiration helpsensure that the potentially bacteria contaminated strips of tissue 502either: do not contact the remaining wound portions after removalbecause of motion and aspiration (thus reducing the chances ofre-infecting the wound); or, if contact is present, that the contact isfor such a short duration, or the contact is on side of the strips oftissue where bacterial have been killed by the plasma, that the chancesof re-infection of the wound 500 are low.

The various embodiments discussed to this point have had two activeelectrodes corresponding to two discharge apertures and two returnelectrodes disposed within fluid conduits defined by the dischargeapertures. However, other numbers of active electrodes and correspondingstructure may be equivalently used. For example, FIG. 6 shows an endelevation view of the distal end 108 of wand 102 comprising a singleactive electrode 600 positioned over a single discharge aperture 602 anda single return electrode 604 disposed within the fluid conduit definedby the discharge aperture. Likewise, FIG. 7 shows an end elevation viewof the distal end 108 of wand 102 comprising an illustrative threeactive electrodes 700, 702 and 704 disposed over a three dischargeapertures 706, 708 and 710, respectively. Much like the otherembodiments, each discharge aperture 706, 708 and 710 defines a fluidconduit, and within the fluid conduit resides three return electrodes712, 714 and 716, respectively. One may use the wand 102 having a distalend 108 as shown in FIG. 6 as the situation dictates, for example forsmaller wounds or wounds in hard to reach locations. Likewise, one mayuse the wand 102 having a distal end 108 as shown in FIG. 7 as thesituation dictates, for example larger wounds and/or areas easier toreach.

The various embodiments discussed to this point have all shown a singleactive electrode spanning a single discharge aperture; however, in otherconfigurations an active electrode may span multiple dischargeapertures. FIG. 8 shows an end elevation view of the distal end 108 ofwand 102 in accordance with other embodiments. In particular, FIG. 8shows an active electrode 800 that spans two distinct dischargeapertures 802 and 804. FIG. 8 also shows optional active electrodes 806and 808, disposed perpendicularly to the active electrode 800. Theoptional active electrodes 806 and 808 may be used to reduce the size ofthe tissue pieces to be taken into the aspiration aperture 204 by theaspiration.

As illustrated in FIG. 1, flexible multi-conductor cable 112 (and moreparticularly its constituent electrical leads) couple to the wandconnector 114. Wand connector 114 couples the controller 104, and moreparticularly the controller connector 120. FIG. 9 shows both across-sectional view (right) and an end elevation view (left) of wandconnector 114 in accordance with at least some embodiments. Inparticular, wand connector 114 comprises a tab 900. Tab 900 works inconjunction with a slot on controller connector 120 (shown in FIG. 10)to ensure that the wand connector 114 and controller connector 120 onlycouple in one relative orientation. The illustrative wand connector 114further comprises a plurality of electrical pins 902 protruding fromwand connector 114. In many cases, the electrical pins 902 are coupledone each to an electrical lead of electrical leads 904, which leads areelectrically coupled to active and return electrodes. Stated otherwise,in a particular embodiment each electrical pin 902 couples to a singleelectrical lead, and thus each illustrative electrical pin 902 couplesto a single electrode of the wand 102. In other cases, a singleelectrical pin 902 couples to multiple electrodes (e.g., multiple activeelectrodes, or multiple return electrodes) on the electrosurgical wand102. While FIG. 9 shows four illustrative electrical pins, in someembodiments as few as two electrical pins, and as many as 26 electricalpins, may be present in the wand connector 114.

FIG. 10 shows both a cross-sectional view (right) and an end elevationview (left) of controller connector 120 in accordance with at least someembodiments. In particular, controller connector 120 comprises a slot1000. Slot 1000 works in conjunction with a tab 900 on wand connector114 (shown in FIG. 9) to ensure that the wand connector 114 andcontroller connector 120 only couple in one orientation. Theillustrative controller connector 120 further comprises a plurality ofelectrical pins 1002 residing within respective holes of controllerconnector 120. The electrical pins 1002 are coupled to terminals of avoltage generator within the controller 104 (discussed more thoroughlybelow). When wand connector 114 and controller connector 120 arecoupled, each electrical pin 1002 couples to a single electrical pin902. While FIG. 10 shows only four illustrative electrical pins, in someembodiments as few as two electrical pins and as many as 26 electricalpins may be present in the wand connector 120.

While illustrative wand connector 114 is shown to have the tab 900 andmale electrical pins 902, and controller connector 120 is shown to havethe slot 1000 and female electrical pins 1002, in alternativeembodiments the wand connector has the female electrical pins and slot,and the controller connector 120 has the tab and male electrical pins,or other combination. In other embodiments, the arrangement of the pinswithin the connectors may enable only a single orientation forconnection of the connectors, and thus the tab and slot arrangement maybe omitted. In yet still other embodiments, other mechanicalarrangements to ensure the wand connector and controller connectorcouple in only one orientation may be equivalently used.

FIG. 11 illustrates a controller 104 in accordance with at least someembodiments. In particular, the controller 104 comprises a processor1100. The processor 1100 may be a microcontroller, and therefore themicrocontroller may be integral with random access memory (RAM) 1102,read-only memory (ROM) 1104, digital-to-analog converter (D/A) 1106,digital outputs (D/O) 1108 and digital inputs (D/I) 1110. The processor1100 may further provide one or more externally available peripheralbusses, such as a serial bus (e.g., I²C), parallel bus, or other bus andcorresponding communication mode. The processor 1100 may further beintegral with a communication logic 1112 to enable the processor 1100 tocommunicate with external devices, as well as internal devices, such asdisplay deice 124. Although in some embodiments the controller 104 mayimplement a microcontroller, in yet other embodiments the processor 1100may be implemented as a standalone central processing unit incombination with individual RAM, ROM, communication, D/A, D/O and D/Idevices, as well as communication port hardware for communication toperipheral components.

ROM 1104 stores instructions executable by the processor 1100. Inparticular, the ROM 1104 may comprise a software program that implementsthe various embodiments of controlling the voltage generator 1116(responsive to commands from the user), as well as interfacing with theuser by way of the display device 124 and/or the foot pedal assembly 130(FIG. 1). The RAM 1102 may be the working memory for the processor 1100,where data may be temporarily stored and from which instructions may beexecuted. Processor 1100 couples to other devices within the controller104 by way of the D/A converter 1106 (e.g., the voltage generator 1116),digital outputs 808 (e.g., the voltage generator 1116), digital inputs1110 (i.e., push button switches 126, and the foot pedal assembly 130(FIG. 1)), and other peripheral devices.

Voltage generator 1116 generates selectable alternating current (AC)voltages that are applied to the electrodes of the wand 102. In variousembodiments, the voltage generator defines two terminals 1124 and 1126.The terminals 1124 and 1126 may couple to active electrodes and returnelectrodes. As an example, terminal 1124 couples to illustrative activeelectrode 206 and terminal 1126 couples to return electrode 210. Inaccordance with the various embodiments, the voltage generator generatesan alternating current (AC) voltage across the terminals 1124 and 1126.In at least some embodiments the voltage generator 1116 is electrically“floated” from the balance of the supply power in the controller 104,and thus the voltage on terminals 1124, 1126, when measured with respectto the earth ground or common (e.g., common 1128) within the controller104, may or may not show a voltage difference even when the voltagegenerator 1116 is active.

The voltage generated and applied between the active terminal 1124 andreturn terminal 1126 by the voltage generator 1116 is a RF signal that,in some embodiments, has a frequency of between about 5 kilo-Hertz (kHz)and 20 Mega-Hertz (MHz), in some cases being between about 30 kHz and2.5 MHz, often between about 100 kHz and 200 kHz. The RMS (root meansquare) voltage generated by the voltage generator 816 may be in therange from about 5 Volts (V) to 1000 V, preferably being in the rangefrom about 10 V to 500 V, often between about 100 V to 350 V dependingon the active electrode size and the operating frequency. Thepeak-to-peak voltage generated by the voltage generator 1116 forablation for wound treatment in some embodiments is a square wave formin the range of 10 V to 2000 V and in some cases in the range of 100 Vto 1800 V and in other cases in the range of about 28 V to 1200 V, oftenin the range of about 100 V to 320V peak-to-peak (again, depending onthe electrode size and the operating frequency).

Still referring to the voltage generator 1116, the voltage generator1116 delivers average energy levels ranging from several milliwatts tohundreds of watts per electrode, depending on the voltage applied forthe target tissue being treated, and/or the maximum allowed temperatureselected for the wand 102. The voltage generator 1116 is configured toenable a user to select the voltage level according to the specificrequirements of a particular procedure. A description of one suitablevoltage generator 1116 can be found in commonly assigned U.S. Pat. Nos.6,142,992 and 6,235,020, the complete disclosure of both patents areincorporated herein by reference for all purposes.

In some embodiments, the various operational modes of the voltagegenerator 1116 may be controlled by way of digital-to-analog converter1106. That is, for example, the processor 1100 may control the outputvoltage by providing a variable voltage to the voltage generator 1116,where the voltage provided is proportional to the voltage generated bythe voltage generator 1116. In other embodiments, the processor 1100 maycommunicate with the voltage generator by way of one or more digitaloutput signals from the digital output 1108 device, or by way of packetbased communications using the communication device 1112 (connection notspecifically shown so as not to unduly complicate FIG. 11).

FIG. 12 shows a method in accordance with at least some embodiments. Inparticular, the method starts (block 1200) and proceed to: flowing aconductive fluid within a fluid conduit disposed within aelectrosurgical wand, the conductive fluid flows past a return electrodedisposed within the fluid conduit, and is then discharged through adischarge aperture (block 1202); applying electrical energy between anactive electrode and the return electrode (block 1204); forming,responsive to the energy, a plasma proximate to the active electrode(block 1206); and treating a wound by placing the active electrodeagainst the wound, and translating the active electrode along the wound(block 1208).

While preferred embodiments of this disclosure have been shown anddescribed, modifications thereof can be made by one skilled in the artwithout departing from the scope or teaching herein. The embodimentsdescribed herein are exemplary only and are not limiting. Because manyvarying and different embodiments may be made within the scope of thepresent inventive concept, including equivalent structures, materials,or methods hereafter though of, and because many modifications may bemade in the embodiments herein detailed in accordance with thedescriptive requirements of the law, it is to be understood that thedetails herein are to be interpreted as illustrative and not in alimiting sense.

What is claimed is:
 1. A method comprising: flowing a conductive fluidwithin a fluid conduit disposed within a electrosurgical wand, theconductive fluid flows past a return electrode disposed within at leasta portion of a fluid path directed through and to contact the returnelectrode before being discharged through a discharge aperture; applyingelectrical energy between an active electrode and the return electrode;forming, responsive to the energy, a plasma proximate to the activeelectrode; and treating a wound by placing the active electrode adjacentto the wound, and translating the active electrode along the wound. 2.The method of claim 1 wherein flowing further comprises flowing theconductive fluid past the return electrode in the form of a coil ofwire.
 3. The method of claim 1 wherein flowing further comprises flowingthe conductive fluid past the return electrode in the form of a coil ofwire that defines a central axis, and wherein the direction of flow ofthe conductive fluid prior to encountering the coil of wire isperpendicular to the central axis.
 4. The method of claim 1 whereinflowing further comprises flowing the conductive fluid past the returnelectrode in the form of a wire mesh.
 5. The method of claim 1 whereinflowing further comprises flowing the conductive fluid such that theconductive fluid is discharged at least partially toward the activeelectrode in the form of loop of wire.
 6. The method of claim 1 furthercomprising aspirating through a fluid aspiration aperture in theelectrosurgical wand, the aspiration aperture adjacent -the dischargeaperture.
 7. The method of claim 1 wherein treating the wound comprisesdetaching at least one wound tissue strip from the wound and aspiratingthe at least one strip away from the wound such that the at least onestrip does not substantially contact an underlying remaining woundportion.
 8. The method of claim 7 wherein detaching the at least onewound tissue strip comprises ablating at least a portion of the woundwithout completely molecularly dissociating the at least one strip. 9.The method of claim 1 wherein treating the wound comprises debriding atleast a portion of the wound and aspirating a plurality of wound tissuestrips away from the wound.
 10. The method of claim 9 wherein the stepsof debriding and aspirating further comprise removing a substantialconcentration of bacteria from the wound.
 11. The method of claim 1wherein the step of flowing a conductive fluid past a return electrodeat least partially diffuses the conductive fluid.
 12. The method ofclaim 1 wherein flowing the conductive fluid further comprisesdischarging the conductive fluid from the discharge aperture at a distalterminus of the wand and towards the active electrode extending distallyfrom the discharge aperture and the distal terminus.
 13. The method ofclaim 12 wherein the fluid flow path extends substantially in a distaldirection as the fluid flows over the return electrode, out of thedischarge aperture and over the active electrode before being at leastpartially aspirated through an aspiration aperture, the aspiratingdrawing at least a portion of the conductive fluid proximally.
 14. Themethod of claim 1 wherein the entire return electrode is recessedproximally from the discharge aperture.